The following data is part of a premarket notification filed by Sheathing Technologies, Inc. with the FDA for Sheathes (non-latex), Sterile.
| Device ID | K990175 |
| 510k Number | K990175 |
| Device Name: | SHEATHES (NON-LATEX), STERILE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHEATHING TECHNOLOGIES, INC. 334 COMMERCIAL ST. San Jose, CA 95112 |
| Contact | Lawrence S Polayes |
| Correspondent | Lawrence S Polayes SHEATHING TECHNOLOGIES, INC. 334 COMMERCIAL ST. San Jose, CA 95112 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40842418100471 | K990175 | 000 |
| 20842418100668 | K990175 | 000 |
| 20842418100620 | K990175 | 000 |
| 20842418100590 | K990175 | 000 |
| 20842418100477 | K990175 | 000 |
| 20842418100446 | K990175 | 000 |
| 20842418100415 | K990175 | 000 |
| 20842418100347 | K990175 | 000 |
| 20842418100293 | K990175 | 000 |
| 20842418100699 | K990175 | 000 |
| 20842418100743 | K990175 | 000 |
| 20842418101641 | K990175 | 000 |
| 30842418100474 | K990175 | 000 |
| 20842418102419 | K990175 | 000 |
| 20842418102341 | K990175 | 000 |
| 20842418101900 | K990175 | 000 |
| 20842418101689 | K990175 | 000 |
| 20842418101672 | K990175 | 000 |
| 20842418101665 | K990175 | 000 |
| 20842418101658 | K990175 | 000 |
| 20842418100248 | K990175 | 000 |